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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 207762

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NDA 207762 describes AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, which is a drug marketed by Alembic, Apotex, Dr Reddys, Mylan, and Neocubes Pharma, and is included in five NDAs. It is available from six suppliers. Additional details are available on the AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM profile page.

The generic ingredient in AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM is amlodipine besylate; atorvastatin calcium. There are fifty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the amlodipine besylate; atorvastatin calcium profile page.

Summary for 207762

Tradename:	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
Applicant:	Neocubes Pharma
Ingredient:	amlodipine besylate; atorvastatin calcium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;EQ 10MG BASE
Approval Date:	Jan 11, 2019	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;EQ 20MG BASE
Approval Date:	Jan 11, 2019	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE;EQ 40MG BASE
Approval Date:	Jan 11, 2019	TE:	AB	RLD:	No

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